Basic technological components are
integrated to establish that they will work together. This is relatively
"low fidelity" compared to the eventual system. Examples include
integration of "ad hoc" hardware in the laboratory.

Non-GLP laboratory research to
refine hypothesis and identify relevant parametric data required for
technological assessment in a rigorous (worst case) experimental design.
Exploratory study of candidate device(s)/systems (e.g., initial
specification of device, system, and subsystems). Candidate
devices/systems are evaluated in laboratory and/or animal models to
identify and assess potential safety problems, adverse events, and side
effects. Procedures and methods to be used during nonclinical and clinical
studies in evaluating candidate devices/systems are identified. The design
history file, design review, and, when required, a master device record,
are initiated to support either a 510(k) or PMA.

Reviewers confirm proof-of-concept and safety of candidate
devices/systems from laboratory test results, laboratory/animal models,
and documentation of the initial design history file, design review, and,
when required, a master device record. The documented initial design
history file, design review, and, when required, a master device record
support either a 510(k) or PMA.